Associate Director, Imaging Operations
1 Days Old
As a Clinical Imaging Operations Associate Director, you will have a leading role in the designing and executing of key operational aspects of complex early and late phase clinical trials with special emphasis in oncology. Imaging includes all modalities, with a focus on CT, MRI, and PET. You will collaborate with Imaging Leads and be fully integrated within clinical teams. You should expect to work closely with several Regeneron functions including clinical operations, data management, and clinical research as well as clinical sites as you provide key oversight of external imaging clinical research organizations (CROs) to insure the successful completion of startup activities, ongoing execution, and close-out of clinical studies. You will also lead a team of highly motivated imaging operation leads.
As an Associate Director, a typical day may include the following:
Designing and implementing study imaging operational components across therapeutic areas (with a focus on oncology) and imaging modalities
Collaborating with vendor relationship management and strategic sourcing & procurement in performance management of imaging CROs at the relationship level through governance
Authoring, reviewing and approving Communication Plans, Standard Operating Procedures, Work Instructions, etc.
Coordinating imaging components of study startup, including input into requests for proposal, authoring of site documents, site assessment questionnaires, and site personnel training
Collaborating closely with data management for imaging data reconciliation
Tracking imaging progress during clinical studies and addressing imaging queries that may come up in close collaboration clinical study teams, sites, and imaging CROs, including functional oversight through periodic monitoring of key performance indicators related to imaging timeliness, quality, etc., query resolution and troubleshooting
Responsibility for direct reports' oversight, development, and day-to-day management
This may be for you if you:
Excel at driving, managing, executing, and delivering results for sophisticated clinical study/program objectives
Proven history of collaborating effectively in a highly matrixed and team-based environment
Are an experienced leader within a Clinical Imaging function and want to see the impact of your work on patients
To be considered for this role we require a BA/BS with 10+ years of industry clinical imaging operations experience. Experience in GCP clinical imaging as a quantitative endpoint in clinical studies, proven organizational capabilities and experience, excellent written and verbal communication skills. Experience with CT, PET and MRI imaging acquisition with modern clinical imaging scanners. Experience in imaging CRO oversight and implementation of quality control procedures. Experience in implementation of standard response criteria in oncology (e.g. RECIST, Lugano, RANO, PCWG3, etc.) Additional experience with regulatory submissions would be a plus.
- Location:
- Bernards
We found some similar jobs based on your search
-
23 Days Old
Associate Director, Imaging Operations
-
Basking Ridge, NJ
-
$150
- Management And Consultancy
As a Clinical Imaging Operations Associate Director, you will have a leading role in the designing and executing of key operational aspects of complex early and late phase clinical trials with special emphasis in oncology. Imaging includes all modali...
More Details -
-
28 Days Old
Associate Director, Imaging Operations
-
Basking Ridge, NJ, United States
- Management & Operations
As a Clinical Imaging Operations Associate Director, you will have a leading role in the designing and executing of key operational aspects of complex early and late phase clinical trials with special emphasis in oncology. Imaging includes all modali...
More Details -